Primary Device ID | 10860004977374 |
NIH Device Record Key | 14dc546e-cf40-4f34-b93b-ab0c0688b65f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | StitchKit |
Version Model Number | SK-109 |
Company DUNS | 079994267 |
Company Name | ORIGAMI SURGICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com | |
Phone | 9737656256 |
info@origamisurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860004977377 [Primary] |
GS1 | 10860004977374 [Package] Contains: 00860004977377 Package: Box [6 Units] In Commercial Distribution |
GCJ | Laparoscope, General & Plastic Surgery |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-22 |
Device Publish Date | 2024-02-14 |
00860088000206 | StitchKit ePTFE Suture Delivery Canister |
00860088000237 | StitchKit® PTFE Suture and Needle Management Device |
00860004977353 | StitchKit® RHP Suture and Needle Management Device |
00860004977346 | StitchKit® RSCP Suture and Needle Management Device |
00860004977339 | StitchKit® PR Suture and Needle Management Device |
10860004977312 | StitchKit® HE Suture and Needle Management Device |
10860004977305 | StitchKit® BA Suture and Needle Management Device |
10860004977381 | StitchKit® URO Suture and Needle Management Device |
10860004977374 | StitchKit® RNY Suture and Needle Management Device |
00860004977322 | StitchKit® EC Suture and Needle Management Device |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STITCHKIT 85662513 4286173 Live/Registered |
Origami Surgical, LLC 2012-06-27 |